Kopran Ltd is expecting Drug Controller General of India's approval for starting clinical trials of its two new chemical entities - KNC-1206 and KNC-6 by the next fortnight. The former is a laxative, while the latter is an anti-ulcer compound. The advanced pre-clinical trials of KNC-6 were completed last year, while that of KNC-1206 in early 2003. The company has applied for the Investigational New Drug Approval of both the molecules.

"We are anticipating DCGI approval for both the molecules within the next 1-2 weeks. The Phase-I trials will be commenced immediately after getting the DCGI approval," said a source close to the company.

KNC-1206 is a synthetic bulk drug polymer, overcoming the drawbacks of existing alternatives such as psyllium and calcium polycarbophil. KNC- 6 is a bio-compatible polymer-based proton pump inhibitor. The compound is cytoprotective and effective in ethanol induced ulcers. Kopran Ltd has already spent around Rs 50 crore so far on its research activities.

The company's managing director Surendra Somani was not available for any comments over the matter despite several attempts to contact him by Pharmabiz.com.

The patent for KNC-6 has been filed globally through PCT route in Feb-2000. National Phase filling has already been initiated in USA (Sept, 2001) and 30 other countries including India.

The patent application for KNC-1206 has been filed globally through PCT route in June 2000. US national phase application has been filed in March 2002.

Kopran's research activities have been undertaken by its 100 per cent subsidiary Kopran Research Laboratories Ltd. There are more than 40 people working on various projects of research. The research department would be expanded in a phased manner to meet the objectives, the source said.

The R&D strategy is divided into: (a) focus on discovery of New Chemical Entities; (b) NDDS; (c) process development; and (d) dosage form development. The New Chemical Entities research is based on basic platform technology, which KRL is willing to discover.